Clinical investigations of medical devices

European legislation and guidelines

 

In order to protect the health and ensure the safety of patients, users and third parties, and for the free movement of medical devices within the EU, in accordance with the ethical recommendations from the World Health Organization (contained in the Declaration of Helsinki) and European Union, the regulatory requirements stated in the Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, in their current versions, must be followed in clinical research with medical devices. This Regulation establish the rights and duties of sponsors, competent authorities and subjects in the research.

The conduct of clinical investigation with medical devices is widely detailed in the standard EN ISO 14155 - Clinical investigation of medical devices for human subjects: Good clinical practice, that presumes compliance with the requirements for clinical investigation described in the above mentioned Regulation.

 

Regulations

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 - on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

 

Guidelines

  • MDCG 2021-8 - Clinical investigation application/notification documents

  • MDCG 2021-6 - Regulation (EU) 2017/745 ¿ Questions & Answers regarding clinical investigation

  • MDCG 2020-13 - Word version - Clinical evaluation assessment report template

  • MDCG 2020-10/1 - Guidance on safety reporting in clinical investigations / MDCG 2020-10/2Appendix: Clinical investigation summary safety report form

  • MDCG 2020-8 - Guidance on PMCF evaluation report template

  • MDCG 2020-7 - Guidance on PMCF plan template

  • MDCG 2020-6 - Guidance on sufficient clinical evidence for legacy devices

  • MDCG 2020-5 - Guidance on clinical evaluation ¿ Equivalence

  • MDCG 2019-9 - Summary of safety and clinical performance

  • MDCG 2020-1 - Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software

  • MDCG 2019-16 rev.1 - Guidance on cybersecurity for medical devices

  • MEDDEV 2.12/1 rev.8 - Guidance document - Market surveillance - Guidelines on a Medical Devices Vigilance System - 

 

More guidelines (European Commission)